(35 days)
The Aurora DS is intended for use in dermatology for non invasive hair removal.
The Aurora DS is indicated for non-invasive hair removal.
The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) hair and follicle without damaging the surrounding tissues.
The provided text is a 510(k) summary for the Syneron Medical Ltd. AURORA DS device. It outlines the company, device description, intended use, and substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on establishing substantial equivalence for a modification (an increase in RF energy output) to an already cleared device. It explains that the modification does not affect intended use or fundamental scientific technology and raises no new safety or effectiveness issues.
Therefore, I cannot provide the requested table and study details as they are not present in the given input.
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AUG = 1 2003
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
SYNERON MEDICAL Ltd. AURORA DS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
- Submitter: Syneron Medical Ltd., Appolo Bld., Industrial Zone Yoqneam Illit, Israel Tel. +972.4.909-7424, Fax +972.4. 909-7417
Name of the Device: Aurora DS
| Predicate Devices: | This is a Special 510(k) for the Aurora DS that was clearedunder K021149 |
|---|---|
| Device Description: | The Aurora DS is a device that is used for non-invasive hairremoval. The Aurora DS treatment is based on a principle ofselective thermolysis. According to this principle, parameters ofoptical and RF energy (spectrum, exposure duration and energydensity) are chosen (and optimized) to selectively damage(destroy) hair and follicle without damaging the surroundingtissues. |
The Aurora DS is intended for use in dermatology for non invasive hair removal.
The modifications to the Aurora DS do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification an increase in the RF energy output. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness.
24 June 2003 Mr. Moshe Mizrahy CEO Syneron Medical Ltd.
Date
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure with three overlapping profiles, suggesting a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure, emphasizing the organization's name and national affiliation. The overall design is simple and professional, conveying a sense of authority and public service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2003
Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical Ltd. Apollo Bld. Industrial Zone P.O Box 550 Yogneam Illit, 20692 Israel
Re: K031988 Trade/Device Name: Aurora DS Regulation Number: 21 CFR 878.4810, 878.4400 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology, Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEX, GEI Dated: June 24, 2003 Received: July 2, 2003
Dear Dr. Waldman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -Dr. Amir Waldman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number
こ
K 031988
Aurora DS Device Name___________________________________________________________________________________________________________________________________________________________________
Indications For Use: (separate page)
The Aurora DS is indicated for non-invasive hair removal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109) OR
Over The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Muriam C-Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031988
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.